covered by a referenced CEP X are considered as intermediates, the details of the manufacturing sites involved in the process for the referenced CEP X should also be mentioned in the application form and in the section “3.2.S.2.1 Manufacturers” of the submission dossier for the new CEP Y....
如何很好地申请CEP证书resentation - EDQM Virtual Training Programme independent modules on the Ph. Eur., reference standards and the CEP Procedure - How to build a good new CEP application by Rita Almeida.pdf,THE EUROPEAN DIRECTORATE FOR THE QUALITY OF ME
PUBLIC DOCUMENT (Level 1)English only/Anglais seulement PA/PH/CEP (11) 76 Strasbourg, July 2012 斯特拉斯堡，2012年7月 Certification of Suitability toMonographs of the European Pharmacopoeia Guidance on frequent changes to applications for Certificates of Suitability (CEPs)欧洲药典适用性证书常见CEP变更...
. (b) Physicalform(e.g.,polymorphicform, solvate, hydrate):to becommentedespecially if requestedasgrade. (c) Solubility andotherpropertiesas necessary. (d) Particlesize:e.g. “non-micronised”, “micronised”orany gradeclaimedassubtitle. 2 6 Page of EDQM PA/PH/CEP(15)26 Certificationof...
The need to present the information mentioned on the CEP (additional testing, retesting period, elemental impurities, etc.) in tabular form for easy consultation was raised by many respondents. Figure 2– Example of an eCTD module for Drug Substance ...
EDQMPA/PH/CEP(04)2,4R CertificationofSubstancesDivision Page3of19 Dateofimplementation:1March2010 Introduction: TheholderofaCertificateofsuitabilityshallinformtheEDQMofanychangetothe informationinthecertificationdossierbysendinganapplicationformandallnecessary ...
Page 2 of 8 EDQM PA/PH/CEP 16) 23 Certification of Substances Division 3.1 Risk Management Summary Provided Applicants should clearly identify this option in their application. A Risk Management Summary report should be provided in module 3 of the dossier, in the form of a Table, as ...
(0) 3 88 41 27 71 Internet : http://www.edqm.eu PA/PH/CEP (04) 1, 4R 1 2 2 CONTENT OF THE DOSSIER FOR A SUBSTANCE FOR CHEMICAL PURITY AND MICROBIOLOGICAL QUALITY EVALUATION The Application Form – Request for New Certificate of Suitability together with the relevant annexes should be...
started to submit their authorisation applications electronically. With regard to a centralised marketing authorisation, this has been the only way for some time. For a Certificate of Suitability (CEP) application both ways can still be used, though: sending in paper form or electronic transmission....
Introduction:The holder of a Certificate of suitability shall inform the EDQM of any change to the information in the certification dossier by sending an application form and all necessary documents demonstrating that the conditions laid down in the present guideline are met.Classification of changes ...